Trial Outcomes & Findings for A Phase 2 Open-label Pilot Study Evaluating MYK-461 in Subjects With Symptomatic Hypertrophic Cardiomyopathy and Left Ventricular Outflow Tract Obstruction (NCT NCT02842242)
NCT ID: NCT02842242
Last Updated: 2021-06-08
Results Overview
Post-exercise peak LVOT gradients are assessed after a treadmill stress test by echocardiography.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
21 participants
Primary outcome timeframe
Baseline and Week 12
Results posted on
2021-06-08
Participant Flow
Participant milestones
| Measure |
Cohort A
Mavacamten 10 to 20 mg/d without background medications
|
Cohort B
Mavacamten 2 to 5 mg/d with beta-blockers allowed.
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
10
|
|
Overall Study
COMPLETED
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Based on available data
Baseline characteristics by cohort
| Measure |
Cohort A
n=11 Participants
Mavacamten 10 to 20 mg/d without background medications
|
Cohort B
n=10 Participants
Mavacamten 2 to 5 mg/d with beta-blockers allowed.
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Mean Age (range)
|
56 years
n=11 Participants
|
58 years
n=10 Participants
|
57 years
n=21 Participants
|
|
Sex/Gender, Customized
Male
|
7 Participants
n=11 Participants
|
5 Participants
n=10 Participants
|
12 Participants
n=21 Participants
|
|
Sex/Gender, Customized
Female
|
4 Participants
n=11 Participants
|
5 Participants
n=10 Participants
|
9 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=11 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=11 Participants
|
10 Participants
n=10 Participants
|
21 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=11 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=11 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=11 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=11 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=11 Participants
|
1 Participants
n=10 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=11 Participants
|
9 Participants
n=10 Participants
|
20 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=11 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=11 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=21 Participants
|
|
Postexercise LVOT gradient
|
103 mm Hg
STANDARD_DEVIATION 50 • n=9 Participants • Based on available data
|
86 mm Hg
STANDARD_DEVIATION 43 • n=9 Participants • Based on available data
|
94.5 mm Hg
STANDARD_DEVIATION 0 • n=18 Participants • Based on available data
|
PRIMARY outcome
Timeframe: Baseline and Week 12Post-exercise peak LVOT gradients are assessed after a treadmill stress test by echocardiography.
Outcome measures
| Measure |
Cohort A
n=8 Participants
Mavacamten 10 to 20 mg/d without background medications
|
Cohort B
n=9 Participants
Mavacamten 2 to 5 mg/d with beta-blockers allowed.
|
|---|---|---|
|
Change in Post-exercise Peak LVOT Gradient From Baseline to Week 12
|
-89.5 mm Hg
Interval -138.3 to -40.7
|
-25.0 mm Hg
Interval -47.1 to -3.0
|
SECONDARY outcome
Timeframe: Baseline and Week 12LVOT gradients are assessed after a treadmill stress test by echocardiography.
Outcome measures
| Measure |
Cohort A
n=11 Participants
Mavacamten 10 to 20 mg/d without background medications
|
Cohort B
n=10 Participants
Mavacamten 2 to 5 mg/d with beta-blockers allowed.
|
|---|---|---|
|
Number of Participants Achieving a Post-exercise Peak LVOT Gradient Response of < 30 mmHg. Gradient < 30 mmHg
|
8 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline and Week 12The scale name is Dyspnea Numeric Rating Scale (NRS). It is intended to measure how much shortness of breath you have had in the past week. 0 = no shortness of breath and 10 = shortness of breath as the worst possible.
Outcome measures
| Measure |
Cohort A
n=10 Participants
Mavacamten 10 to 20 mg/d without background medications
|
Cohort B
n=10 Participants
Mavacamten 2 to 5 mg/d with beta-blockers allowed.
|
|---|---|---|
|
Change in Dyspnea Symptom Score From Baseline to Week 12
|
-3.1 units on a scale
Interval -4.1 to -2.1
|
-3.0 units on a scale
Interval -5.0 to -1.0
|
SECONDARY outcome
Timeframe: Baseline and Week 12Peak VO2 is assessed using a cardiopulmonary exercise test.
Outcome measures
| Measure |
Cohort A
n=10 Participants
Mavacamten 10 to 20 mg/d without background medications
|
Cohort B
n=10 Participants
Mavacamten 2 to 5 mg/d with beta-blockers allowed.
|
|---|---|---|
|
Change in Peak VO2 From Baseline to Week 12
|
3.5 mL/kg/min
Interval 1.2 to 5.9
|
1.7 mL/kg/min
Interval 0.03 to 3.3
|
SECONDARY outcome
Timeframe: Baseline and Week 12VE/VCO2 is assessed from cardiopulmonary exercise testing results.
Outcome measures
| Measure |
Cohort A
n=10 Participants
Mavacamten 10 to 20 mg/d without background medications
|
Cohort B
n=10 Participants
Mavacamten 2 to 5 mg/d with beta-blockers allowed.
|
|---|---|---|
|
Change in VE/VCO2 From Baseline to Week 12
|
-2.2 Ratio
Interval -6.1 to 1.7
|
-2.5 Ratio
Interval -4.3 to -0.7
|
SECONDARY outcome
Timeframe: Baseline and Week 12LVEF is assessed by echocardiography.
Outcome measures
| Measure |
Cohort A
n=10 Participants
Mavacamten 10 to 20 mg/d without background medications
|
Cohort B
n=10 Participants
Mavacamten 2 to 5 mg/d with beta-blockers allowed.
|
|---|---|---|
|
Change in Resting LVEF From Baseline to Week 12
|
-14.6 Percent change
Interval -23.1 to -6.2
|
-5.5 Percent change
Interval -9.8 to -1.2
|
SECONDARY outcome
Timeframe: Baseline and Week 12LVFS is assessed using echocardiography measures.
Outcome measures
| Measure |
Cohort A
n=10 Participants
Mavacamten 10 to 20 mg/d without background medications
|
Cohort B
n=8 Participants
Mavacamten 2 to 5 mg/d with beta-blockers allowed.
|
|---|---|---|
|
Change in LV Fractional Shortening (LVFS) From Baseline to Week 12
|
-18.60 Percent
Standard Deviation 13.05
|
-3.98 Percent
Standard Deviation 11.42
|
SECONDARY outcome
Timeframe: Baseline and Week 12GLS is assessed using echocardiography measures.
Outcome measures
| Measure |
Cohort A
n=9 Participants
Mavacamten 10 to 20 mg/d without background medications
|
Cohort B
n=10 Participants
Mavacamten 2 to 5 mg/d with beta-blockers allowed.
|
|---|---|---|
|
Change in Global Longitudinal Strain (GLS) From Baseline to Week 12
|
0.56 Percent
Standard Deviation 3.778
|
0.18 Percent
Standard Deviation 2.806
|
SECONDARY outcome
Timeframe: Weeks 12 and 16Post-exercise peak LVOT gradients are assessed after a treadmill stress test by echocardiography.
Outcome measures
| Measure |
Cohort A
n=8 Participants
Mavacamten 10 to 20 mg/d without background medications
|
Cohort B
n=10 Participants
Mavacamten 2 to 5 mg/d with beta-blockers allowed.
|
|---|---|---|
|
Change in Post-exercise Peak LVOT Gradient From Week 12 to Week 16
|
55.22 mm Hg
Standard Deviation 40.84
|
84.08 mm Hg
Standard Deviation 28.38
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Week 12Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Week 12Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 weeksOutcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Week 12Post-exercise peak LVOT gradients are assessed after a treadmill stress test by echocardiography.
Outcome measures
Outcome data not reported
Adverse Events
Cohort A
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Cohort B
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort A
n=11 participants at risk
Mavacamten 10 to 20 mg/d without background medications
|
Cohort B
n=10 participants at risk
Mavacamten 2 to 5 mg/d with beta-blockers allowed.
|
|---|---|---|
|
Cardiac disorders
Atrial Fibrillation
|
9.1%
1/11 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
0.00%
0/10 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
Other adverse events
| Measure |
Cohort A
n=11 participants at risk
Mavacamten 10 to 20 mg/d without background medications
|
Cohort B
n=10 participants at risk
Mavacamten 2 to 5 mg/d with beta-blockers allowed.
|
|---|---|---|
|
Cardiac disorders
Ventricular Tachycardia
|
9.1%
1/11 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
40.0%
4/10 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
|
Cardiac disorders
Atrial Fibrillation
|
27.3%
3/11 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
10.0%
1/10 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
|
Nervous system disorders
Headache
|
27.3%
3/11 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
20.0%
2/10 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
|
Nervous system disorders
Dizziness
|
9.1%
1/11 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
30.0%
3/10 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
|
Gastrointestinal disorders
Nausea
|
18.2%
2/11 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
0.00%
0/10 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
|
Cardiac disorders
Angina Pectoris
|
0.00%
0/11 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
20.0%
2/10 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
|
General disorders
Fatigue
|
18.2%
2/11 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
20.0%
2/10 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
|
General disorders
Application Site Rash
|
0.00%
0/11 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
20.0%
2/10 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (Exertional)
|
18.2%
2/11 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
0.00%
0/10 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
9.1%
1/11 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
20.0%
2/10 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
|
Infections and infestations
Urinary Tract Infection
|
18.2%
2/11 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
0.00%
0/10 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
|
Investigations
Ejection Fraction Decreased
|
27.3%
3/11 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
0.00%
0/10 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
|
Skin and subcutaneous tissue disorders
Rash
|
18.2%
2/11 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
0.00%
0/10 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
|
Cardiac disorders
Cardiac Failure
|
9.1%
1/11 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
0.00%
0/10 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
|
Cardiac disorders
Cardiac Flutter
|
9.1%
1/11 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
0.00%
0/10 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
|
Cardiac disorders
Palpitations
|
9.1%
1/11 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
0.00%
0/10 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
|
Cardiac disorders
Tachycardia
|
9.1%
1/11 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
0.00%
0/10 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
|
Cardiac disorders
Ventricular extrasystoles
|
9.1%
1/11 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
0.00%
0/10 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
|
Eye disorders
Visual impairment
|
9.1%
1/11 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
0.00%
0/10 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
9.1%
1/11 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
0.00%
0/10 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/11 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
10.0%
1/10 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/11 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
10.0%
1/10 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
|
Gastrointestinal disorders
Food Poisoning
|
9.1%
1/11 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
0.00%
0/10 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
|
Gastrointestinal disorders
Gastric Ulcer
|
9.1%
1/11 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
0.00%
0/10 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/11 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
10.0%
1/10 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
|
Gastrointestinal disorders
Retching
|
9.1%
1/11 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
0.00%
0/10 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
|
Gastrointestinal disorders
Vomiting
|
9.1%
1/11 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
0.00%
0/10 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
|
Vascular disorders
Hypertension
|
9.1%
1/11 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
10.0%
1/10 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
|
General disorders
Application Site Erythema
|
9.1%
1/11 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
0.00%
0/10 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
|
General disorders
Asthenia
|
9.1%
1/11 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
10.0%
1/10 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
|
General disorders
Chills
|
9.1%
1/11 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
0.00%
0/10 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
|
General disorders
Feeling Abnormal
|
9.1%
1/11 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
0.00%
0/10 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
|
General disorders
Oedema peripheral
|
9.1%
1/11 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
0.00%
0/10 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
|
General disorders
Peripheral Swelling
|
0.00%
0/11 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
10.0%
1/10 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/11 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
10.0%
1/10 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/11 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
10.0%
1/10 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/11 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
10.0%
1/10 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/11 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
10.0%
1/10 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
|
Injury, poisoning and procedural complications
Fall
|
9.1%
1/11 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
10.0%
1/10 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
|
Injury, poisoning and procedural complications
Heat exhaustion
|
0.00%
0/11 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
10.0%
1/10 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/11 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
10.0%
1/10 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/11 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
10.0%
1/10 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/11 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
10.0%
1/10 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/11 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
10.0%
1/10 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
|
Investigations
Blood calcium decreased
|
0.00%
0/11 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
10.0%
1/10 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
|
Investigations
Blood creatine phosphokinase abnormal
|
9.1%
1/11 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
0.00%
0/10 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
|
Investigations
Brain natriuretic peptide increased
|
9.1%
1/11 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
10.0%
1/10 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
|
Investigations
Heart rate irregular
|
9.1%
1/11 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
10.0%
1/10 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/11 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
10.0%
1/10 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
9.1%
1/11 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
0.00%
0/10 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
9.1%
1/11 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
0.00%
0/10 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/11 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
10.0%
1/10 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
|
Nervous system disorders
Hypersomnia
|
0.00%
0/11 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
10.0%
1/10 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
|
Nervous system disorders
Hyporeflexia
|
0.00%
0/11 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
10.0%
1/10 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/11 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
10.0%
1/10 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/11 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
10.0%
1/10 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
|
Nervous system disorders
Tremor
|
9.1%
1/11 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
0.00%
0/10 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
|
Psychiatric disorders
Anxiety
|
9.1%
1/11 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
0.00%
0/10 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/11 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
10.0%
1/10 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
|
Reproductive system and breast disorders
Breast mass
|
0.00%
0/11 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
10.0%
1/10 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/11 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
10.0%
1/10 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.00%
0/11 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
10.0%
1/10 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.1%
1/11 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
10.0%
1/10 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
9.1%
1/11 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
0.00%
0/10 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/11 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
10.0%
1/10 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/11 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
10.0%
1/10 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
9.1%
1/11 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
10.0%
1/10 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
9.1%
1/11 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
0.00%
0/10 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
9.1%
1/11 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
10.0%
1/10 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
9.1%
1/11 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
0.00%
0/10 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
|
Skin and subcutaneous tissue disorders
Cold sweat
|
9.1%
1/11 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
0.00%
0/10 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
9.1%
1/11 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
0.00%
0/10 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/11 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
10.0%
1/10 • 16 Weeks
Adverse event data were collected from baseline through the end of study visit at Week 16 for each participant enrolled.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee PI's have the right to publish data after the primary publication is released.
- Publication restrictions are in place
Restriction type: OTHER